metformin hydrochloride

Generic: metformin hydrochloride

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3518
Product ID 68071-3518_230dcecd-8f28-d624-e063-6394a90ae9cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213320
Listing Expiration 2026-12-31
Marketing Start 2023-01-19

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713518
Hyphenated Format 68071-3518

Supplemental Identifiers

RxCUI
861007
UPC
0368071351897
UNII
786Z46389E

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name metformin hydrochloride (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA213320 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68071-3518-3)
  • 60 TABLET in 1 BOTTLE (68071-3518-6)
  • 180 TABLET in 1 BOTTLE (68071-3518-8)
  • 90 TABLET in 1 BOTTLE (68071-3518-9)
source: ndc

Packages (4)

68071-3518-3 30 TABLET in 1 BOTTLE (68071-3518-3) 68071-3518-6 60 TABLET in 1 BOTTLE (68071-3518-6) 68071-3518-8 180 TABLET in 1 BOTTLE (68071-3518-8) 68071-3518-9 90 TABLET in 1 BOTTLE (68071-3518-9)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

METFORMIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "230dcecd-8f28-d624-e063-6394a90ae9cf", "openfda": {"upc": ["0368071351897"], "unii": ["786Z46389E"], "rxcui": ["861007"], "spl_set_id": ["0710e208-5b2c-3c72-e063-6394a90a4dac"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-3518-3)", "package_ndc": "68071-3518-3", "marketing_start_date": "20240926"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68071-3518-6)", "package_ndc": "68071-3518-6", "marketing_start_date": "20231006"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (68071-3518-8)", "package_ndc": "68071-3518-8", "marketing_start_date": "20231006"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68071-3518-9)", "package_ndc": "68071-3518-9", "marketing_start_date": "20231006"}], "brand_name": "METFORMIN HYDROCHLORIDE", "product_id": "68071-3518_230dcecd-8f28-d624-e063-6394a90ae9cf", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68071-3518", "generic_name": "metformin hydrochloride", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA213320", "marketing_category": "ANDA", "marketing_start_date": "20230119", "listing_expiration_date": "20261231"}